EP2874604A1 - Use of an amphoteric chelating agent for preventing contact allergies - Google Patents
Use of an amphoteric chelating agent for preventing contact allergiesInfo
- Publication number
- EP2874604A1 EP2874604A1 EP13747452.4A EP13747452A EP2874604A1 EP 2874604 A1 EP2874604 A1 EP 2874604A1 EP 13747452 A EP13747452 A EP 13747452A EP 2874604 A1 EP2874604 A1 EP 2874604A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- chelating agent
- contact
- allergies
- representing
- ethylene diamine
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/16—Emollients or protectives, e.g. against radiation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
- A61K2800/51—Chelating agents
Definitions
- the present invention relates to the field of products for preventing contact allergies.
- Natural rubber or latex is an aqueous emulsion of spherical polyisoprene droplets wrapped in a layer of water soluble proteins. It can be of synthetic or natural origin. In natural form it comes from the sap of Hevea brasiliensis. He is very present in the objects of everyday life. Examples of objects made of latex or comprising latex which are therefore likely to cause allergic reactions include household gloves, tires, balloons, teats, diving tubes, fins, swimming goggles, swim caps, glues, grips tennis racket grips, condoms, medical equipment: elastic bandages, syringes with rubber gaskets, probes, pads, infusion sets, dental gutters and gloves exams or surgeons, etc.
- the present invention relates to the use of at least one amphoteric chelating agent which comprises a complex based on aluminum and ethylene diamine tetraacetic acid or its trisodium salt having the general formula [Al (Y ) B n] c 'c D with B representing OH ⁇ , ⁇ B0 2, H +, Y representing a tetracarboxylate can be protonated four times to form the ethylene diamine tetraacetic acid, n is an integer equal to 0, 1, 2 or 3, D being a counter-ion, preferably Na + , c being an integer of 0, 1, 2 or 3 and c 'being a relative number having the same absolute value as c, to prevent allergies of contact.
- the present invention relates to a device comprising a portion of allergenic material, in particular latex, intended to come into contact with the skin or the mucous membranes, which is covered by a layer containing at least one amphoteric chelating agent such as mentioned above.
- the present invention relates to the use of a composition comprising at least said amphoteric chelating agent mentioned above and at least one excipient, to prevent contact allergies.
- the present invention relates to the use of at least one amphoteric chelating agent which comprises a complex based on aluminum and ethylene diamine tetraacetic acid or its trisodium salt having the general formula [Al (Y) n B] c ' D c with B representing OH " , B0 2 " , H + , Y representing a tetracarboxylate which can be protonated four times to form ethylene diamine tetraacetic acid, n being an integer of 0, 1, 2 or 3, D being a counterion, preferably Na + , where c is an integer equal at 0, 1, 2 or 3 and c 'being a relative number having the same absolute value as c, to prevent contact allergies, in particular rubber allergies.
- contact allergies means all allergies that are caused by repeated contact with the skin and / or mucous membranes of allergenic substances.
- allergens present in objects or devices likely to come into contact with the skin and / or the mucous membranes and which cause contact allergies mention may be made of latex proteins, heavy metals such as Al, As , Cd, Cr, Hg, Ni, Pb, Sr and Te, tetramethylthiuram disulfide, 2-mercaptobenzothiazole, benzyl carbamate, bisphenol, ethyl acrylate, araldite 506 epoxy Resin, methanal, Protein-type allergens (such as profilins, tropomyosins, LTPs (lipid transfer proteins), betv 1-like PR-10 proteins, polcalcines, beta parvalbumin, 2s albumin, beta expansins , polygalacturonases, Ag5 (antigens 5), albumins, caseins, lipocalins, group 5 grass
- the invention is particularly suitable for the prevention of allergies to rubber, and particularly to natural rubber.
- "rubber allergies” means allergies caused by the proteins present in the natural rubber derived from the Hevea brasiliensis tree, but also by other allergenic substances present in the rubber. Examples of such allergenic proteins include hevein, prohevein, profilin, elongation factor of rubber, endo-1,3-glucosidase, and the like.
- non-protein allergenic substances present in the rubber are vulcanizing agents (thiurams, dithiocarbamates, benzothiazoles, guanidines, and thioureas), antioxidants or antiozonants (PPD derivatives - phenylene paradiamine and quinolines), phenols ( hydroquinones), phosphites ... or other additives such as chlorhexidine digluconate, dimethyl didecyl ammonium chloride salts, isothiazolinones, formaldehyde, various metals, etc.
- vulcanizing agents thiurams, dithiocarbamates, benzothiazoles, guanidines, and thioureas
- antioxidants or antiozonants PPD derivatives - phenylene paradiamine and quinolines
- phenols hydroquinones
- phosphites ... or other additives such as chlorhexidine digluconate, dimethyl didecyl ammonium chloride salts, is
- Such contact allergies are manifest as contact dermatitis, contact urticaria, eczema, rhinitis, conjunctivitis, asthma, anaphylactic shock.
- amphoteric chelating agent of general formula [Al (Y) n B] c 'c D used according to the invention can be preferably formed by a substantially stoichiometric combination of aluminum ion Al 3+, Y ligand and a stabilizing agent chosen from OH ⁇ , B02 ⁇ or H + .
- a stabilizing agent chosen from OH ⁇ , B02 ⁇ or H + chosen from OH ⁇ , B02 ⁇ or H + .
- said complex based on aluminum and Y is stabilized by a weak base such that the amino acids chosen from the group comprising glycine, histidine, arginine, lysine, phenylalanine alanine, isoleucine, leucine, methionine, proline, valine, tryptophan, serine, glutamine, cystine and mixtures thereof.
- Glycine is quite appropriate.
- amphoteric chelating agent is carried out so that it is in contact with the skin and / or the mucous membranes.
- Langerhans cells are dendritic cells that are found in the epidermis and contain Birbeck granules. They normally exist in lymph nodes and in the skin in the stratum spinosum of the epidermis. These cells specialized in the capture of antigens are activated when the skin is put in contact with an allergen. This presents a first sign of the beginning of an awareness process. Immunolabelling methods, in particular CDla surface receptors of Langerhans cells make it possible to measure their number and to observe their migration from the epidermis to the dermis.
- the preventive composition of the invention is effective if the antigen is stopped, that is to say not captured by epidermal Langerhans cells. These will not migrate to the dermis.
- the effectiveness of the composition according to the invention is therefore measured by the number of non-migrating Langerhans cells per centimeter of epidermis. No significant migration of the number of these cells has been observed after contacting the skin zone covered by the composition. according to the invention with allergenic agents and in particular with the allergenic proteins of natural rubber such as hevein.
- the invention also relates to a device comprising a portion of material capable of containing allergens for contact with the skin or the mucous membranes, which is covered by a layer containing at least one amphoteric chelating agent which comprises a d-based complex.
- aluminum and ethylene diamine tetraacetic acid or its trisodium salt having the general formula [Al (Y) B n ] c D c with B representing OH " , B0 2 " , H + , Y being a tetracarboxylate which may be protonated four times to form ethylene diamine tetraacetic acid, where n is an integer of 0, 1, 2 or 3, D being a counterion, preferably Na + , where c is an integer of 0, 1, 2 or 3 and c 'being a relative number having the same absolute value as c.
- the invention is particularly suitable for rubber devices or having a rubber part intended to come into contact with the skin and / or the mucous membranes.
- Examples of devices according to the invention are condoms, gloves, finger cots, dressings and compresses, medical devices such as probes, tubing, drainage devices, infusion devices, medical devices useful in urology, medical devices of the invention. first respiratory, etc.
- At least the part of the device intended to come into contact with the skin and / or the mucous membranes is covered with a film comprising said amphoteric chelating agent.
- Said film is preferably a lubricating preparation.
- both the outer surface and the inner surface may be coated with a lubricating preparation comprising said amphoteric chelating agent so as to prevent both partners from experiencing latex allergies.
- the invention also relates to the use of a composition
- a composition comprising at least one amphoteric chelating agent which comprises a complex based on aluminum and ethylene diamine tetraacetic acid or its trisodium salt having the general formula [Al (Y) B n ] c ' D c with B representing OH ⁇ , ⁇ 2 ⁇ , H + , Y representing a tetracarboxylate that can be protonated four times to form ethylene diamine tetraacetic acid, n representing an integer equal to 0, 1, 2 or 3, D being a counterion, preferably Na + , where c is an integer equal to 0, 1, 2 or 3 and c 'is a relative number having the same absolute value as c, and at least one excipient, for prevent contact allergies and especially rubber allergies.
- composition may be in the form of an oil-in-water or water-in-oil emulsion, in the form of a gel, in particular a hydrophilic gel or a silicone gel.
- Said excipient present in the composition is an excipient of pharmaceutical or cosmetic quality.
- excipients that may be present in the composition according to the invention are chosen from a gelling agent, surfactants, synthetic or natural waxes or oils, moisturizing and emollient agents, antiperspirants, additives improving texture such as conditioners and thickeners, preservatives, cosmetic and food colorants, fragrances, flavorings, pH control agents and mixtures thereof.
- the gelling agent or thickener may be hydrophilic or may be of the silicone type.
- the hydrophilic gelling agents may be synthetic, semi-synthetic or natural gelling agents of plant, microbial, animal or mineral origin.
- Hydrophilic gelling agents may be, for example, polymers and copolymers of acrylic acid, crosslinked polymers, C 10-30 alkyl acrylate, polyacrylamide, poloxamer, cellulose derivatives (esters and ethers), silicas, fumed silica, silicates , such as magnesium-aluminum silicates, chitin and its derivatives, gelatin, xanthan, dextran, gellan, carrageenans, alginates, agar-agar, agar, pectin, acacia gum, karaya gum, gum tragacanth, gum arabic, gum guar, locust bean gum, starch and its derivatives, scleroglucan.
- concentration of gelling agent or thickener is from 0.01 to 10% by weight, preferably from 0.1 to 5% by weight, and more preferably from 0.5 to 3% by weight of the total weight of the composition.
- the silicone-type gelling agent is, for example, a polysiloxane-s-.
- the surfactant may be hydrophobic with a HLB of 3 to 10 or hydrophilic with an HLB of 11 to 18.
- This surfactant is selected from the group consisting of ethoxylated fatty alcohols, fatty acids and esters (eg Example: ceteart-12, ceteart-20, ceteareth-33, stearyl cetyl alcohol 20-ethoxylated, 2-polyhydroxystearate polyglyceryl, glyceryl oleate, sorbitan ester, glycerol ester, PEG-mono / di-laurate, PEG-mono / di stearate, cetearyl isononanoate, glyceryl stearate, etc.), carboxylates, ethoxycarboxylates (for example: sodium / potassium stearate, alkyl carboxylic acid, carboxylic acid alkyl polyglycol ether, carboxylic acid ether polyglycol alkyl phenol, carboxy
- Waxes or synthetic or natural oils selected from the group comprising carnauba extract, beeswax, shea butter, triglycerides, stearines, fatty acid esters (for example: cetearyl alcohols, cetyl palmitate dicapryl ethers, dicaprylic carbonates, cetearyl isononanates, distearyl-tricarbonate dimers, etc.), silicone oils, zinc stearates, polyisobutenes, octyldodecanol, octyldecylxylosides, fatty alcohols, fatty acids (eg lauric acid) , myristic acid, stearic acid, etc.), vegetable oils (for example: sunflower, jojoba, coconut nucifera, soya, almond, etc.), petroleum jelly, lanolin, and mixtures thereof.
- fatty acid esters for example: cetearyl alcohols, cetyl palmitate dicapryl ethers, dicaprylic carbon
- the moisturizing and emollient agents may be chosen from the group comprising allantoin, polyol (for example glycerol, glycerol polymers, propylene glycol, sorbitol, etc.), plant extracts (for example extracts of aloe vera, chamomile, cucumber). calendula, etc.), hyaluronic acid, pyrrolidone carboxylic acid, urea, chitosan, tocopherol, panthenol, butylene glycol, phospholipid, linoleic acid, ⁇ -linoleic acid, alpha-bisabolol, and mixtures thereof.
- polyol for example glycerol, glycerol polymers, propylene glycol, sorbitol, etc.
- plant extracts for example extracts of aloe vera, chamomile, cucumber). calendula, etc.
- hyaluronic acid for example extracts of aloe ver
- the concentration of moisturizing and emollient agents is from 0.1 to 20% by weight, preferably from 0.5 to 10% by weight, and more preferably from 1 to 5% by weight of the total weight of the composition.
- the antiperspirants may be selected from the group consisting of aluminum salts, preferably the sesqui-aluminum hydrochloride, aluminum and zirconium salts, complexes of aluminum-zirconium octachlorohydrex glycine and mixtures thereof.
- concentration of antiperspirant agent is 0.1 to 50% by weight, preferably 10 to 30% by weight, and more preferably 15% by weight of the total weight of the composition.
- Conditioners may be selected from the group consisting of polycationic polymers designated according to the INCI polyquaternium nomenclature, quaternized gums, quaternized phospholipids, and mixtures thereof.
- the conditioner concentration is from 0.1 to 20% by weight, preferably from 0.5 to 10% by weight, and more preferably from 0.5 to 5% by weight of the total weight of the composition.
- the preserving agents may be chosen from the group comprising: para-hydroxybenzoic alkyl ester, isothiazolinone, imidazolidinyl urea, diazolidinyl urea, bromo-nitro-propanediol, phenoxyethanol, sorbic acid and its salts, benzoic acid and its salts, phenoxyethanol, benzyl alcohol, and mixtures thereof.
- the concentration is the one authorized in cosmetics.
- the concentration of cosmetic and food colorants, perfumes, flavorings, pH-regulating agents eg citric acid, lactic acid, phosphoric acid, sodium hydroxide, potassium hydroxide, amino-methylpropanol, triethanolamine, etc.
- concentration of cosmetic and food colorants, perfumes, flavorings, pH-regulating agents eg citric acid, lactic acid, phosphoric acid, sodium hydroxide, potassium hydroxide, amino-methylpropanol, triethanolamine, etc.
- pH-regulating agents eg citric acid, lactic acid, phosphoric acid, sodium hydroxide, potassium hydroxide, amino-methylpropanol, triethanolamine, etc.
- the composition is a gelling preparation, in particular a lubricating preparation.
- the lubricating preparation is a hydrophilic preparation, a silicone preparation or a vaseline lubricating preparation containing said amphoteric chelating agent or in liquid form or in solid form.
- the amount of amphoteric chelating agent present in said composition is from 0.01 to 5%, preferably from 0.02 to 4.4% and more preferably from approximately 2% by weight of the total weight of the composition.
- the amounts of allergens are very low, especially when using deproteinized latex, very small amounts, even less than 0.01%, could be sufficient. However, in most cases less than 0.01% does not provide a sufficient preventive effect. Beyond 5%, no noticeable improvement is observed.
- the composition is used for topical application, more particularly cutaneous. It can also be used by application on the surface of the device intended to come into contact with the skin and / or the mucous membranes.
- the present inventors are of the opinion that the composition according to the invention makes it possible to provide a physical and chemical barrier against allergens. More particularly, after application and drying, a barrier layer covers the skin thus ensuring a physical barrier between the skin and the external environment, the amphoteric chelating agent ensuring a chemical barrier by chelating or chemically reacting with the incoming allergens. in contact with this composition.
- the composition must completely cover the area of skin and / or mucosa that may come into contact with the latex device, typically hands for latex gloves or sex for condoms. It must be applied over the entire contact area.
- the amount of application of the composition according to the invention is in the proportion of approximately 0.5 to 5 mg / cm 2 , preferably of approximately 1 to 3 mg / cm 2 , and still more preferably of approximately 1, 5 mg / cm 2.
- amphoteric chelating agent used has the following formula: [A1YB02] 2-
- the gel is prepared as follows: the water is poured into a container. It is stirred while adding the gum and the amphoteric chelating agent. Let stand 10 min.
- Brookfield viscosity 18000 cP measured at a temperature of 20 (+/- 1) ° C and with a mobile speed at 3/20 rpm
- BEM medium BIO-EC Explant Medium
- Example 3 The composition of Example 3 is tested against the following allergens:
- Heavy metals Al, As, Cd, Cr, Hg, Ni, Pb, Sr, Te
- V Ref 0C467028 Merck
- Araldite 506 Epoxy Resin - A3183;
- a TB is applied the composition of Example 3 above on the skin explants at a dosage of 3 mg / cm 2. It is allowed to dry for 15 minutes.
- 25 ⁇ l of a solution of one of the allergens chosen from the above list are applied to the skin explants protected by the emulsion of Example 3 (test) and are also applied to non-skin explants. -protected (witness). It is left to rest until T 4h , which represents 4 hours of exposure to the allergen without washing or abrasive friction.
- emulsion-protected explants are prepared in the same way but are not brought into contact with a test substance (control).
- the protective efficacy against allergens is measured by the immunostain analysis of CDla.
- the paraffin sections of Langerhans cells are immunostained with anti-CDla monoclonal antibodies (ref IM1590, clone O10, Beckman Coulter) for 1 hour at ambient temperature. This immunostaining is enhanced by a streptavidin / biotin system (Vector, PK-7200) and revealed using VIP (Vector, SK-4600).
- the nuclei are counterstained by Masson hemalum. Langerhans cells are counted on each section along the epidermis. The length of each section is measured by the Olympus Cell software and the average number of Langerhans cells per centimeter of epidermis is calculated.
- the effectiveness of protection against the allergen is measured by the number of Langerhans cells that have not migrated.
- Figure 1 shows the explants at T 0 and Figure 2 at T 4h for hevein.
- the stratum corneum is thin, compact and moderately filled with keratin on the surface and remarkably below.
- the epidermis has 4-5 cell layers with good morphology and mild spongiosis on stratum germinativum.
- the junction relief between the dermis and the epidermis is marked.
- the papillary dermis has fairly thick fibers that build a dense network and is well cellularized without any apparent histological lysis zone.
- the epidermis of unprotected explants presents 4-5 cell layers with remarkable morphological changes. These changes are characterized by marked cytoplasmic denaturation (protein alteration), marked pycnosis and marked spongiosis on stratum germinativum.
- Example 3 protects the skin effectively against hevein.
- lubricant comprising:
- This gel is applied by coating on the inner and outer sides of a natural rubber preservative in an amount of 2.0 +/- 0.5 mg / cm 2 .
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Abstract
Description
Claims
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PL13747452T PL2874604T3 (en) | 2012-07-18 | 2013-07-17 | Use of an amphoteric chelating agent for preventing contact allergies |
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FR1256939A FR2993466B1 (en) | 2012-07-18 | 2012-07-18 | USE OF A PROTECTIVE CREAM AGAINST THE EFFECTS OF AGGRESSIVE CHEMICAL AGENTS IN CONTACT WITH THE SKIN |
PCT/FR2013/051718 WO2014013195A1 (en) | 2012-07-18 | 2013-07-17 | Use of an amphoteric chelating agent for preventing contact allergies |
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EP13747452.4A Active EP2874604B1 (en) | 2012-07-18 | 2013-07-17 | Use of an amphoteric chelating agent for preventing contact allergies |
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US5587400A (en) * | 1993-04-19 | 1996-12-24 | Marie-Claude Blomet epouse Meyer | Physiological composition for the treatment of thermal or chemical burns |
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FR2809959B1 (en) * | 2000-06-07 | 2004-10-29 | Marie Claude Meyer | USE OF ALUMINUM COMPLEX AND LIGAND ETHYLENEDIAMINE-TETRAACETIC FOR THE PREVENTION AND / OR TREATMENT OF URTICARIA |
GB0403702D0 (en) * | 2004-02-19 | 2004-03-24 | Boots Co Plc | Skincare compositions |
GB0324084D0 (en) * | 2003-10-14 | 2003-11-19 | Oxagen Ltd | Compounds |
JP2007508363A (en) * | 2003-10-14 | 2007-04-05 | オキサジェン リミテッド | Compound having CRTH2 antagonist activity |
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